Counterfeit Diabetes Medications

The Internet allows consumers to shop for deals on anything imaginable, even prescription drugs. The economic struggles that many currently face, paired with the increasing cost of healthcare and prescription drugs, have created an environment in which counterfeit drug makers can prosper.

The drugs offered by counterfeiters can be extremely dangerous, even deadly. Most either have little or no active ingredient, are too potent, and/or have dangerous impurities. According to a 60 Minutes investigation in Peru, highway paint, floor wax, boric acid, and other harmful ingredients were being used to manufacture drugs. These ingredients are a small sample of the potentially dangerous ingredients that have made their way into counterfeit drugs.

The enormous profits earned by counterfeiters are attributable to cheap manufacturing costs along with high resale prices. It is estimated that counterfeit drug rings bring in $75 to $200 billion annually. Profits can exceed those of heroin and cocaine.

Counterfeits are so well made that the pills look identical to the real thing when inspected with the naked eye. Unfortunately, sometimes these look-alikes are deadly. For example, a case in 2009 from China revealed that counterfeit glibenclamide (glyburide in the U.S.) resulted in nine hospitalizations and two deaths.  The drugs were shown to have six times the labeled amount of glibenclamide.

Counterfeit drugs are generally more prevalent in Asia, India, and developing countries, but the U.S. is not immune to the threat. 60 Minutes reported, “Forty percent of drugs taken in the country [U.S.] come from other countries, and 80 percent of active pharmaceutical ingredients actually come from other countries.”

In the U.S., drug manufacturers sell to authorized distributors who then sell to pharmacies, but this supply chain can become tainted with counterfeit drugs when secondary wholesalers enter the market. Authorized distributors or foreign countries may supply these secondary wholesalers, and it is at this point that counterfeits may enter circulation.  

Erectile dysfunction drugs (Viagra, Cialis) and cholesterol-lowering agents (Lipitor) are among the most heavily counterfeited drugs. In 2008, 150 non-diabetics in Singapore presented with severe hypoglycemia after ingesting erectile dysfunction drugs laced with glyburide. Seven remained comatose for an undisclosed amount of time, and four deaths resulted. In 2003, the FDA recalled various lots of counterfeit Lipitor. Although there were no reported deaths or harmful events, this event testifies to the fact that even legitimate distribution channels are vulnerable to counterfeits.  

Although the majority of reports are tied to drugs, a case arose in 2006 in which counterfeit glucose test strips made their way into U.S. circulation. The FDA reported no injuries related to the event, but the situation could have seriously harmed patients who used the faulty strips. Falsely high readings may have caused patients to inject unnecessary quantities of insulin, which could have caused severe hypoglycemia and possibly death. Fortunately, this did not occur, but the test strips are yet another example of how counterfeit products can make their way into circulation and the potential severity of the issue.  

The problem of counterfeits is more prevalent in less developed countries, but legitimate distribution channels have been breached, and no one is immune to the problem. Internet pharmacies are a prime example of how counterfeits get into the hands of consumers around the world. Internet pharmacies often advertise medications at a fraction of the cost a retail pharmacy would charge, and some even allow one to purchase prescription products without a prescription.  The low cost and absence of a prescription are some of the ways these sites market to their potential clientele, but what sometimes slips the mind of the consumer is the potential hazard that comes with these so-called benefits.

The aforementioned cases are only a small sampling of the global problem. Counterfeits could potentially be found in any pharmacy, but are most likely to be encountered with Internet pharmacies. The consumer should be wary of this and understand some of the signs that may indicate a counterfeit. Counterfeit pills may look or taste differently than usual, may be chipped, may be ineffective (lead to an exacerbation of symptoms), or may have side effects not listed in the drug profile.

Pharmaceutical companies are beginning to use tracking technology on their products to curb the incidence of counterfeits. In 2006, the World Health Organization implemented IMPACT, a task force to combat counterfeiters and protect the consumer. While IMPACT may help the situation, it will not rid the market of counterfeited products. Consequently, consumers, healthcare providers, and various organizations must continue to work together to combat this problem.

References
1. Darnton et al. The Difficult Fight Against Counterfeit Drugs [Internet]. CBS Interactive Inc; 2011 Mar 10 [Cited 2011 May 25]; [4 pages]. Available from:    http://www.cbsnews.com/stories/2011/03/10/60minutes/main20040693.shtml?tag=currentVideoInfo;segmentTitle.
2. Chu, Kathy. Growing Problem of Fake Drugs Hurting Patients, Companies [Internet]. USA Today; 2010 Sept 13 [Cited 2011 May 25]; [ 2 pages]. Available from: http://www.usatoday.com/money/industries/health/2010-09-12-asia-counterfeit-drugs_N.htm.
3. Kao SL, Chan CL, Lim CC, et al. An Unusual Outbreak of Hypoglycemia. N Engl J Med. 2009 Feb 12; 360(7): 734-736.
4. A Serious Threat to Patient Safety: Counterfeit Pharmaceuticals [Internet]. New York: Pfizer; 2007; [16 pages]. Available from: www.pfizer.com/files/products/CounterfeitBrochure.pdf.